BO44157 - RO7247669 plus tiragolumab v atezolizumab in advanced urothelial bladder cancer

• Research type

  Research Study

• Full title

  A PHASE II, RANDOMIZED, MULTICENTER, OPEN LABEL, CONTROLLED STUDY OF RO7247669 ALONE OR IN COMBINATION WITH TIRAGOLUMAB VERSUS ATEZOLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER WHO ARE INELIGIBLE FOR PLATINUM-CONTAINING CHEMOTHERAPY

• IRAS ID

  1006563

• Contact name

  Head of Clinical Trials Regulatory Management

• Contact email

  global.eudract@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2022-002265-15

• Research summary

  The purpose of this study is to compare the effects, good or bad, of RO7247669 alone or in combination with tiragolumab versus atezolizumab on patients with bladder cancer.
  RO7247669 and tiragolumab are experimental drugs, and health authorities have not approved RO7247669 alone or in combination with tiragolumab for the treatment of bladder cancer.
  Each participant’s total time in the study will depend on how their bladder cancer responds to treatment. This could range from 1 day to more than 30 months. The participants will attend hospital approximately every 3 weeks during this time. Visits may last 1-8 hours . Approximately 15 participants will take part in the study in the UK at 5 Sites and 240 worldwide.

  This is an open-label, randomized study and participants will be randomized to one of the following three treatment groupsarms.
  Group 1Arm A: Atezolizumab
  – Patients will receive atezolizumab by intravenous infusion (into a vein) on Day 1 of each 21-day cycle
  ● Group 2Arm B: RO7247669
  – Patients will receive RO7247669 by intravenous infusion on Day 1 of each 21-day cycle
  ● Group 3Arm C: RO7247669  Tiragolumab
  – Patients will receive RO7247669 by intravenous infusion in combination with tiragolumab on Day 1 of each 21-day cycle

  Eligible participants are those who have urothelial cancer that is locally advanced or metastatic and their doctor has determined that they should not receive platinum-based chemotherapy

  The study is sponsored by F. Hoffman La Roche

  Research Summary; Version Number 1 dated 16 June 2022;

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  23/EM/0012

• Date of REC Opinion

  22 Aug 2023

• REC opinion

  Further Information Favourable Opinion